510(k) DEN140040
DEN140040 is an FDA 510(k) premarket notification submitted by Jan Medical, Inc. for the device "Nautilus BrainPulse 1000". The FDA issued a decision of De Novo Granted on August 1, 2016. The device falls under product code POP (Cranial Motion Measurement Device), a Class II device regulated under 21 CFR 882.1630. Jan Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 1, 2016
- Date Received
- December 23, 2014
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cranial Motion Measurement Device
- Device Class
- Class II
- Regulation Number
- 882.1630
- Review Panel
- NE
- Submission Type
A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.